(40 days)
The ABL 77 pH, Blood Gas and Electrolyte Analysis System is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The ABL 77 pH, Blood Gas and Electrolyte Analysis System can be used in the laboratory, near patient, or point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial and venous whole blood samples.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets the acceptance criteria.
The document is a 510(k) clearance letter from the FDA for the "ABL 77 pH, Blood Gas and Electrolyte Analysis System." While it establishes that the device is substantially equivalent to a legally marketed predicate device, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, or ground truth establishment.
- Information about expert involvement, adjudication methods, or MRMC studies.
- Any mention of standalone algorithm performance or training set details.
This document indicates the device has received FDA clearance for marketing, but the specifics of its performance testing and acceptance criteria are not included in this particular letter.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.